Why Confirm Biosciences

Choosing the right partner is about more than just products—

it’s about performance, precision, and partnership. At Confirm Biosciences, we bring more than two decades of experience, unmatched regulatory expertise, and end-to-end service that helps our partners go to market with confidence.

TheConfirm BiosciencesAdvantage

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Certifications&Compliance

circle-chevron-right circle-chevron-up ISO 13485 Certification

Confirm Biosciences holds ISO 13485 certification, the global standard for quality management in medical devices and related services. This certification ensures our products meet strict regulatory requirements, maintain consistent quality, and deliver safe, reliable results—giving our partners confidence in every solution we provide.

circle-chevron-right circle-chevron-up UL Retail Certification Program (RCP)

Confirm Biosciences is certified through the UL Retail Certification Program (RCP). This quality assurance initiative ensures the safety, compliance, and performance of our private-label and sourced products.

circle-chevron-right circle-chevron-up FDA 510(K) Classified & CLIA-Waived Products

Confirm Biosciences offers FDA 510(k) classified and CLIA-waived diagnostic products, meeting strict federal standards for safety, accuracy, and reliability. These designations ensure our solutions deliver trusted results while remaining simple to use in a variety of testing environments.

circle-chevron-right circle-chevron-up De Novo Granted Products

Confirm Biosciences offers de novo granted diagnostic products, recognized by the FDA as safe and effective with no prior equivalent on the market. This designation underscores our commitment to innovation and advancing reliable testing solutions.

circle-chevron-right circle-chevron-up MDSAP Manufacturer Partner

Confirm Biosciences partners with manufacturers certified under the Medical Device Single Audit Program (MDSAP), ensuring compliance with the highest international quality and regulatory standards across multiple global markets.

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What Our Partners Say

  • Confirm Biosciences has always offered exceptional customer service, products, and is a leader in the industry. I wouldn’t change anything!

    Director of Sales and Business Development Medical Supply Company

  • I have enjoyed working with all of you. Anytime I have questions or concerns, you never hesitate to stop and take the time for me. I really appreciate all of you!

    IOP Coordinator Recovery and Wellness Center

  • Excellent Supplier, Service, and quality is always a priority. Thanks for having in mind our interest in a long term partnership. We appreciate all you do for us. Thank you!

    Procurement Specialist Retailer
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Supply Chain

pallet-package Distribution

Work with consolidation partners for delivery to customers on-time and in full

todo Compliance

Expertise in adhering to retailer routing guides

basket-fast Procurement

World class buying/planning processes to ensure reliable supply

plug-2 EDI Integration

Deep expertise in EDI integration

truck-fast Logistics Hub

Warehousing & Fulfillment

Let’s bring tomorrow closer

We’ve been waiting for a partner like you.

Get in Touch View Our Products Private Labelling